| CTRI Number |
CTRI/2025/01/079241 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare between two devices that allows delivering oxygen to the patient during a surgical procedure. |
|
Scientific Title of Study
|
Comparison of Laryngeal Mask Airway Protector and Intubating Laryngeal Mask Airway for Ease of Fiberoptic-Guided Tracheal Intubation in Adult Patients: A One-Year Hospital-Based Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kevin Santosh Joseph |
| Designation |
Junior resident |
| Affiliation |
KLE DR Prabhakar Kores hospital |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9108774021 |
| Fax |
|
| Email |
kevinjoseph787@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh Mane |
| Designation |
Professor and HOD |
| Affiliation |
KLE DR Prabhakar Kores hospital |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rajesh Mane |
| Designation |
Professor and HOD |
| Affiliation |
KLE DR Prabhakar Kores hospital |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India- 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Kevin Santosh Joseph |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India- 590010 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kevin Santosh Joseph |
KLE DR Prabhakar Kores hospital |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India- 590010
Belgaum
KARNATAKA |
9108774021
kevinjoseph787@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intubating LMA |
After induction of general anaesthesia, intubating LMA of size #3 or #4 will be inserted depending on the weight of the patient and checked for bilateral air entry. After confirming bilateral air entry a flexible fiberoptic scope will be used to visualize the position of vocal cords and the patients will be intubated using 7mm ID flexometallic tube. Following which the patient will again be checked for bilateral air entry. |
| Comparator Agent |
LMA protector |
After induction of general anaesthesia, LMA protector size #3 or #4 will be inserted depending on the weight of the patient and checked for bilateral air entry. After confirming bilateral air entry a flexible fiberoptic scope will be used to visualize the position of vocal cords and the patients will be intubated using 7mm ID flexometallic tube. Following which bilateral airentry will be confirmed. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA status I, II, III
Patients undergoing elective surgery under general anaesthesia
Patients willing to give consent
|
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency surgeries
Patients not willing to give consent
Patients with pharyngeal pathology
Patients having anatomical deformity of mouth, pharynx and larynx
Patients with high risk for aspiration
Patients with high airway resistance (severe obesity)
Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the ease for fibreoptic-guided tracheal intubation through the Intubating LMA with the LMA Protector. |
0 minutes, (Intraoperative) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the position of the LMA Protector and Intubating LMA with respect to the glottic aperture. |
0 minutes, (Intraoperative) |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway management is crucial during general anesthesia and emergencies, with difficult intubation rates ranging from 0.05% to 18%. Supraglottic airway devices (SADs) are effective alternatives, offering high success rates for blind insertions and ease of use without extensive training. Fiberoptic-guided tracheal intubation improves success compared to blind techniques, requiring clear visibility of the glottic aperture through the SAD. However, limited studies compare SADs for fiberoptic intubation, highlighting the need for further research. |